中国随机药物试验中主要结局转换与报告试验结果之间的关联。

Association between switching of primary outcomes and reported trial findings among randomized drug trials from China.

机构信息

Bloomberg School of Public Health, The Johns Hopkins University, Baltimore, MD, USA.

Blood Station, Tongzhou, Beijing, China.

出版信息

J Clin Epidemiol. 2021 Apr;132:10-17. doi: 10.1016/j.jclinepi.2020.11.023. Epub 2020 Dec 9.

DOI:10.1016/j.jclinepi.2020.11.023

PMID:33309887

Abstract

BACKGROUND AND OBJECTIVE

To evaluate the association between the nature of findings and the switching of registered primary outcomes among randomized controlled trials (RCTs) from mainland China.

METHODS

This is a retrospective cohort study. We retrieved RCTs from trial registries and identified the corresponding journal articles from bibliographic databases until August 2019. Trial registries and journal articles were compared to evaluate whether registered primary outcomes with negative findings were more likely to be switched to secondary outcomes in the subsequent journal articles than those with positive findings.

RESULTS

Switching of registered primary outcomes occurred in 131 (45%) of 294 RCTs. A total of 450 registered primary outcomes were matched to 522 (37%) primary outcomes and 871 (63%) secondary outcomes in the journal articles. Among RCTs registered before they started, the odds of switching primary outcomes with negative findings were 2.64 (95% CI: 1.16-6.02) times the odds of switching those with positive findings. Among RCTs registered when they were ongoing, the odds of switching primary outcomes with negative findings were 8.84 (95% CI: 3.62-25.93) times the odds of switching those with positive findings.

CONCLUSION

The nature of findings may play a role in how likely a prespecified primary outcome is switched subsequently.

摘要

背景与目的

评估中国大陆随机对照试验（RCT）中研究结果的性质与主要结局指标转换之间的关联。

方法

这是一项回顾性队列研究。我们从试验注册库中检索 RCT，并从文献数据库中确定相应的期刊文章，检索时间截至 2019 年 8 月。我们比较了试验注册库和期刊文章，以评估具有阴性研究结果的注册主要结局指标是否更有可能在随后的期刊文章中转换为次要结局指标，而非具有阳性研究结果的注册主要结局指标。

结果

在 294 项 RCT 中，有 131 项（45%）发生了注册主要结局指标的转换。共有 450 个注册的主要结局指标与期刊文章中的 522 个（37%）主要结局指标和 871 个（63%）次要结局指标相匹配。在注册前开始的 RCT 中，阴性研究结果的主要结局指标转换的可能性是阳性研究结果的 2.64 倍（95%CI：1.16-6.02）。在正在进行注册的 RCT 中，阴性研究结果的主要结局指标转换的可能性是阳性研究结果的 8.84 倍（95%CI：3.62-25.93）。